FDA 510(k) Application Details - K232568

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K232568
Device Name	Powered Laser Surgical Instrument
Applicant	IPG Medical Corporation 225 Cedar Hill Street Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Samuel D Wade Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2023
Decision Date	03/21/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review